Nasal tampon

ABSTRACT

A self-retaining nasal tampon particularly designed to control nasal hemorrhaging, comprising, according to one embodiment, an elongated flexible tube open at one end and sealed at its opposite end, a hollow bulbous portion formed on the tube adjacent the open end thereof, such bulb preferably being molded integral with the tube, an inflatable member or sleeve surrounding and sealingly attached to the closed end of the tube, and which may also include a second inflatable member or sleeve sealingly attached to and surrounding an intermediate portion of the tube, passage means communicating the interior of the tube with such inflatable member or members to permit inflation thereof by fluid introduced into the tube, and sealing means positioned within the tube to permit facile inflation of each of the inflatable members or sleeves independently of each other to form respective inflated bags or balloons, and to retain such bags in their inflated position, and also to permit selective deflation of such inflated bags when desired, for removal of the device from the nasal passage, the bulb mounted adjacent the open end of the tube functioning to anchor the tube in position in the nasal passage without danger of the tube slipping into the throat and obstructing the airway.

United States Patent [191 Gottschalk Nov. 26, 1974 NASAL TAMPON [76] Inventor: George H. Gottschalk, 8618 S.

Sepulveda Blvd, Los Angeles, Calif. 90045 22 Filed: Oct. 9, 1973 21 Appl. No.: 404,267

Related US. Application Data [63] Continuation-impart of Ser. No. 224,172, Feb. 7,

1972, abandoned.

[52] US. Cl. 128/325 [51] Int. Cl A61b 17/12 [58] Field of Search 128/325, 348, 129, 344, 128/349 B, 246, 342; 137/223; 251/5, 61.1; 46/90 [56] References Cited UNITED STATES PATENTS 1,534,913 4/1925 Buck et al 128/274 X 3,570,484 3/1971 Steer 128/274 Primary Examiner-Richard A. Gaudet Assistant ExaminerHenry J. Recla Attorney, Agent, or Firm-Lyon & Lyon [57] ABSTRACT A self-retaining nasal tampon particularly designed to control nasal hemorrhaging, comprising, according to one embodiment, an elongated flexible tube open at one end and sealed at its opposite end, a hollow bulbous portion formed on the tube adjacent the open end thereof, such bulb preferably being molded integral with the tube, an inflatable member or sleeve surrounding and sealingly attached to the closed end of the tube, and which may also include a second inflatable member or sleeve sealingly attached to and surrounding an intermediate portion of the tube, passage means communicating the interior of the tube with such inflatable member or members to permit inflation thereof by fluid introduced into the tube, and sealing means positioned within the tube to permit facile inflation of each of the inflatable members or sleeves independently of each other to form respective inflated bags or balloons, and to retain such bags in their inflated position, and also to permit selective deflation of such inflated bags when desired, for removal of the device from the nasal passage, the bulb mounted adjacent the open end of the tube functioning to anchor the tube in position in the nasal passage without danger of the tube slipping into the throat and obstructing the airway.

11 Claims, 18 Drawing Figures NASAL TAMPON This application is a continuation-in-part of my application Serial No. 224,172, filed February 7, 1972, now abandoned.

This invention relates to a self-retaining nasal or nasopharyngal tampon, and is particularly concemed with a tampon of the above type which can be readily inserted into the nasal passage to control nasal hemorrhaging without the need of packing the nose with gauze, and which includes one or a plurality of inflat able members which can be readily inflated selectively when the device is inserted into the nasal passage, the inflatable members when inflated in the form of a bag or balloon functioning to fill the nasal cavity and supplying the necessary pressure for hemostasis, and particularly including self-sustaining means provided at one end of the tube and adapted to anchor the tube in the nasal passage so that the tube remains in fixed position in the nasal passage when the inflatable member or members are either in the deflated or the inflated condition.

Inflatable bag catheters employed in various body drainage procedures are well known in the art, employing various techniques for inflation of such catheters for retention in their proper position in the body region in which they are placed.

However, a particular need has arisen for a relatively simple nasal tampon for use in controlling nasal hemorrhaging and post-adenoidectomy bleeding, which can be employed without the need of packing the nose with gauze, and which tampon can be readily inserted into the nasal passage and can be quickly and easily inflated to form one or more balloons which fill the nasal cavity and/or the nasopharynx to supply the necessary pressure for hemostasis, and including means to retain the tampon in the nasal passage and/or the nasopharynx for any desired period, and which balloonor balloons can be readily deflated as desired for easy and painless removal from the nasal cavity.

An improved nasal tampon achieving the above requirements is disclosed in my US. Pat. No. 3,570,494. According-to the'patent, there is provided a nasal tampon comprising an elongated flexible, e.g. rubber'tube, a plurality of inflatable sleeves sealingly surrounding the tube, at least one such inflatable sleeve located adjacent the outer closed end of the tube and one such inflatable sleeve adjacent the open inner end of the tube, with passage means between the interior of the tube and each of the inflatable sleeves for selective inflation thereof.

Although the above-noted nasal tampon of my patent has proved highly effective in practice, it has been found that the danger exists that in the event the inflatable member or sleeve positioned at the inner end of the tube and which in the inflated position serves to anchor the device by contact with the exterior of the nostrils, becomes deflated; for example by accident, or when the device is to be removed from the nasal passage, the patient may aspirate the device.

As a particular feature of the present invention, in order to overcome and avoid such possible danger of aspirating the device, there is provided adjacent the open end of the tube in place of the inflatable anchoring member of the device of my above patent, a hollow self-sustaining bulb formed on the tube and which at all times, by contact with the outside of the nose adjacent the nostrils-maintains the nasal tampon in fixed position after being inserted into the nasal passage, whether or not the inflatable member or members sealingly attached around the outer closed end of the tube, and also around the intermediate portion of the tube, are in the inflated operative position within the nasal passage,

or are in the deflated position, for example, following deflation thereof and preparatory to removal of the device from the nasal passage. Such bulb according to the preferred embodiment is mounted integral with the tube, as by molding thereof on the tube.

The provision of such anchoring means in the form of the above-noted bulb, which is semi-rigid and has a substantially larger diameter than the diameter of the tube, avoids all danger of the patient inadvertently aspirating the device when it is inserted into the nasal passage, either beforeor after the inflatable member or members also carried on the tube have been inflated into their operative position.

According to the present invention, there is thus pro vided according to one embodiment, a nasal tampon comprising an elongated flexible tube open at one end and closed at its opposite end, the above-noted hollow bulb carried on the tube adjacent the open end thereof, an inflatable member or sleeve surrounding and sealingly attached around the closed outer end of the tube, passage means communicating the interior of the tube with the inflatable member to permit inflation thereof by fluid introduced into the tube and the inflatable member via the passage means, when the device is disposed within the nasal passage, and sealing means, eg in the form of a soft rubber plug, positioned within the tube, preferably adjacent the open end thereof, such plug being capable of being punctured as by the needle of a syringe, for inflating the inflatable member, and being resealable upon removal of the needle. Puncture of such rubber plug by the syringe needle permits introduction of inflating fluid via the passage means located in the wall of the flexible tube, into the inflatable sleeve to permit inflation of the rubber plug by the syringe needle and withdrawal of fluid from such sleeve.

' According to another embodiment, a second inflatable member is sealingly attached to the tube and disposed around the flexible tube intermediate the ends thereof and between the above-noted first mentioned inflatable member disposed around the closed outer end of the tube, and the bulb, passage means communicating the interior of the tube and the second inflatable member to permit inflation thereof by fluid introduced into the second inflatable member, and a second sealing means, e.g. in the form of a soft rubber plug also po- 1 sitioned within the tube and spaced from the abovenoted first mentioned sealing means or plug, such second plug also being capable of being punctured by asyringe needle, the respective sealing means permitting selective inflation and deflation of the two inflatable members.

According to a preferred modification, particularly employed when the device carries a plurality, e.g. two, inflatable members, there is also provided an insert for introduction into the inner end of the tube, such insert containing channels, with the sealing means, e.g. soft rubber plugs, inserted into such channels, the sleeve also containing passageways registering with the passage means in the tube, such passageways communicating with the respective inflatable members via the passage means thereto in the wall of the elongated tube.

Such insert is beneficial,particularly where there are a plurality of sealing means in the form of softrubber plugs which are to be punctured by the syringe needle,-

to prevent inadvertent puncture of the wall of the inflatable tube by the needle of the syringe when it is passed into and withdrawn from each of the respective plugs for inflation or deflation of the respective inflatable members. Such insert can be of the type shown and described in my above patent.

The invention will be more clearly understood by reference to the description below of the various embodiments of the invention, taken in connection with the accompanying drawing wherein:

FIG. 1 illustrates application of the nasal tampon of V the invention, showing one embodiment of the device of the invention inserted into the nasal passage and the inflatable members inflated into operative position to control hemorrhaging and to retain. the device in position in the nasal passage;

FIG. 2 illustrates one preferred embodiment of the invention device, employing a pair of inflatable membus;

end of tube 10 a hollow symmetrical bulb 14 is provided, the bulb 14 having a substantially larger diameter than the diameter of the tube 10, and being semirigid. The size or outer diameter of the bulb is such that it will function to securely anchor the device when inserted in the nose cavity, the bulb serving as an anchor against the under surface of the nose adjacent the nostrils as described in detail below. Thus, for example, the outer diameter of tube 10 can be inch and the outer diameter of bulb 14 can be about inch, but it will be understood that these dimensions are only exemplary and in no way limiting. Such bulb, as shown in FIG. 2, preferably is integral with the tube itself, as by molding such bulb on the tube during fabrication thereof, so that the bulb is preferably semi-rigid.

Thus, one of the inflatable members 12 is positioned around the outer end portion 22 of flexible tube 10 and extends around the closed end 18 of the tube, such inflatable member 12 being circumferentially sealed or adhered at its inner edge 24 to the outer wall of the flexible tube 10 by suitable means such as adhesives,

FIG. 2a is an enlarged detail of a portion of the de- 7 vice of FIG. 2;

FIG. 2b is a section taken on line 2b-2b of FIG. 2;

FIG. is a section taken on line 2c2c of FIG. 2;

FIG. 3 illustrates a modification of the device of FIG.-

2, and without employing any insert;

FIG. 4 illustrates the modification of FIG. 3, including a metal insert or metal sleeve;

FIG. 5 is a section taken on line 55 of FIG. 4;

FIG. 6 illustrates a second preferred embodiment of the invention device, employing a single inflatable member disposed around the closed end of the tube;

FIG. 7 is a modification of the embodiment of FIG. 6;

FIG. 8 shows a modification of the device wherein the bulb is not integral-with the tube, but is attached thereto by suitable means;

FIG. 9 is a side'elevation with parts broken away showing a presently preferred embodiment of the invention; v p p v FIG. 10 is a view similar to'FIG. 9 showing an inflating device in position;

FIG. 11 is an enlarged fragmentary sectional view taken on the line 11-11 of FIG. 9;

FIG. 12 is a view similar to FIG. 11 taken on the line 12 12 of FIG. 10;

FIG. 13 is a transverse sectional view taken on the line l3l3 of FIG. 11;

1 FIG. 14 is a transverse sectional view taken on the line 14-14 of FIG. 12; and

FIG. 15 is a perspective view of the valve element of this embodiment.

Referring to FIGS. 1 and 2 of the drawing, showing one preferred embodiment of the invention device, and its mode of application, numeral 10 is an elongated flexible tube, preferably formed of rubber, but which can be formed of any suitable flexible plastic material, having two inflatable elastic members or sleeves 12 and 16 surrounding and sealingly attached to the tube 10, such tube being closed at one end as indicated at 18, termed herein the outer end of the tube, and being open at its other end, as indicated at 20, and termed herein the inner end of such tube. Adjacent the inner heat sealing or vulcanization, the remainder of the inflatable member or sleeve 12 remaining unattached so that the member 12 upon inflation forms a bag or balloon surrounding the outer end portion of tube 10, as indicated by the dotted line 26.

The large middle elastic inflatable member or sleeve 16 disposed between the inflatable member 12 and the bulb 14 is circumferentially sealed at its opposite circumferential edges 28 and 28 as by an adhesive, heat sealing or vulcanization to the outer wall of the tube 10, the remainder of member 16 being unattached so that such member upon inflation forms a large central bag or balloon surrounding the middle portion of the tube 10, as indicated by the dotted lines '30. In the embodimerit shown in FIG. 2, it will be noted that the opposite outer edges 28 and 28 of the middle large inflatable member or sleeve 16 are disposed close to the adjacent peripheralsealed edge 24 of inflatable member 12, and

the inner side 14 of the'hollow bulb 14.

The flexible tube 10 has a series of peripheral apertures 36, e.g. four in number, in the tube wall adjacent the outer end 18 of tube 10, the apertures 36 being equally spaced from each other and being disposed in a plane substantially normal to the axis of tube 10. The apertures 36 are positioned to provide communication between the interior of tube 10 and the interior of outer inflatable member 12. Tube 10 carries on its outer surface a short tube 35 which is positioned adjacent the inner side 14' of bulb 14. Tube 35 is preferably molded on the tube 10, and is provided with a passage 34. The aperture 34 in short tube 35 provides communication between the interior of bulb l4 and tube 10, and the interior of the middle large inflatable member 16.

Disposed within the open end 20 of tube 10 is a metal sleeve 38, the outer wall of which fits snugly against the inner surface of the wall of tube 10, the sleeve 38 being open at its opposite ends and containing a shoulder 40 which sealingly abuts the edge 42 of the tube 10, adjacent the base of the bulb 14, to position the sleeve 38 properly within the tube 10. The sleeve 38 is preferably firmly attached to the inner surface of the wall of tube 10, e.g. by a suitable adhesive, although not necessarily if the fit is sufficiently tight to prevent leakage between the outer wall of the sleeve and inner wall of tube 10. The sleeve 38 passes through the. interior of bulb l4 and has a series of apertures 44, shown as four in number, and when the sleeve is properly positioned within the tube 10, the apertures 44 in the sleeve 38 communicate via the interior of bulb 14 with the passage 34 of the tube 35, to permit fluid communication between the interior of sleeve 38 and of inflatable member 16.

Within the sleeve 38 there are provided two separate plugs 46 and 48, such plugs being formed of soft rubber having characteristics such that they can be punctured, as by a hypodermic needle of a syringe, but upon removal of such needle, the plugs are resealable. Plug 46 is disposed adjacent the outer open end 50 of the sleeve 38, and to the left of the apertures 44 therein, and plug 48 is disposed adjacent the inner open end 52 of sleeve 38 and spaced from plug 46, plug 48 being disposed to the right of apertures 44 in sleeve 38.

It is thus seen that plug 46 forms an enclosed space 54 between plug 46 and the closed end 18 of tube 10, and communicating via apertures 36 with the interior of inflatable member 12, and spaced plugs 46 and 48 form an enclosed space 56 communicating via apertures 44 and 34 with the interior of the large inflatable intermediate member 16.

In operation, to control nasal hemmorhage, the nasal tampon of the invention illustrated in FIG. 2 is inserted with the closed end 18 of tube first, through the nostril 66 and into the nasal cavity or passage 68 of a person, with the outer closed end 18 of the tube positioned adjacent the inner end of the nasal passage, i.e., adjacent the nasopharynx 70 leading to the throat, the middle portion of tube 10 surrounded by the large inflatable member 16 disposed entirely within nasal cavity 68, and the outer side 14 of the bulb 14 adjacent the inner end 20 of the tube, being disposed just outside nostril 66 and anchoring the device in position in the nasal passage. The hypodermic needle 72 of a syringe 74 is pushed through plugs 48 and 46 in succession until the end of the hypodermic needle is disposed just to the left of plug 46 and communicating with the enclosed space 54 in the outer portion of tube 10. The position of the end of the needle through plug 46 and extending into space 54 can be ascertained by means of a mark 76 at the base of needle 72, when such mark is disposed adjacent the inner end 20 of tube 10. The fluid, e.g. air, from the syringe is then injected into the enclosed or sealed portion 54 of tube 10 and via apertures 36 into the inflatable member 12 to inflate same to the proper extent as illustrated at 26 in FIGS. 1 and 2. In this inflated position as seen in FIG. 1, the bag 26 is disposed under pressure against the adjacent walls of the nasopharynx at the inner end of the nasal cavity, retaining the device in this position and restraining movement thereof outwardly, as indicated by arrow 77 in FIG. 1.

After inflation of bag 12, which is indicatedto the operator or physician by an increased back pressure in the syringe 74, the needle 72 is withdrawn through the forward plug 46, closing the plug and rescaling the enclosed space 54, thus preventing fluid from escaping from member 12, and maintaining member 12 in its inflated condition 26. When another intermediate marking 78 on the needle 72 is adjacent the inner end 20 of tube 10, this indicates that the end of the needle 72 is now disposed in the enclosed space 56 between plugs 46 and 48. Fluid from the syringe 74 is then injected into the enclosed space 56 and via the apertures 44 in sleeve 38 and passage 34 in short tube 35, into the large inflatable intermediate member 16, and the member 16 is then inflated until the surfaces thereof are in tight engaging contact with a substantial portion of the inner surfaces 80 and 82 of the nasal passage 68, the resulting inflated bag or balloon now being in the position indicated at 30 in FIGS. 1 and 2. This inflated position of member 16 is again signaled by a rise in back pressure in the syringe 74.

In position 30 of the large middle inflatable member 16, as illustrated in FIG. 1, the inflated bag 30 is under sufiicient pressure against the walls 80 and 82 of the nasal passage to effectively function to prevent or control hemorrhage or bleeding from the major portion of the inner walls of the nasal cavity 68, and to effectively plug the nasal cavity until hemorrhaging is arrested. Upon withdrawing the inner end of needle 72 from plug 48, the plug closes the needle-formed opening therein so that space 56 becomes enclosed and sealed and no fluid escapes therefrom or from the balloon l6, and such bag or balloon remains inflated.

The inflated balloons as indicated at 26 and 30, and the bulb l4 effectively maintain and anchor the device in operative position within the nasal cavity 68, as indicated in FIG. 1, until hemorrhaging is effectively controlled or ceases. The balloons 26 and 30 can then be deflated by first passing the needle through plugs 48 and 46 into space 54, and withdrawing the fluid from inflated balloon 26 to deflate same, the needle is then withdrawn from plug 46 into space 56, and withdrawing fluid from the large inflated middle balloon 30, followed by complete withdrawal of the needle 72 through plug 48. After deflation of the inflated balloons 26 and 30, the device can be pulled from the nasal cavity 68 through the nostril 66.

It will be seen that when the inflated balloons 26 and 30 are deflated, either as result of withdrawal of fluid from such balloons or as a result of possible rupture of such balloons when in their operative position, since the device is anchored by means of the bulb 14 against the nostrils, the device cannot be displaced to the left, as viewed in FIG. 1, and hence cannot be inadvertently aspirated by the patient prior to its being removed in the normal manner through the nostrils, to the right viewing FIG. 1. j

In conjunction with such positive anchoring of the device in the nasal passage by means of the bulb 14, it

- is seen that the inflatable members 12 and 16 can be selectively inflated individually and independently of each other, rapidly and in any desired sequence. This provides a means for readily and quickly controlling nasal hemorrhage and bleeding, particularly in emergencies, and can be operated easily by any technician or physician, without being a specialist in nose and throat medicine.

In the event it is desired to employ the device of FIG. 2 for control of postadenoidectomy bleeding which takes place in the nasopharynx 70, then only the inflatable bag 12 around the closed end of the tube is inflated, without inflating bag 16. Under these conditions the inflated bag 26 under pressure against the walls of the nasopharynx controls postadenoidectomy bleeding.

The embodiment illustrated in FIG. 3 is similar to that illustrated in FIG. 2, except that in FIG. 3 the sleeve 38 is not employed. In FIG. 3 the plugs 46 and 48 are positioned within the flexible tube 10, the plug 46 being disposed within tube 10 adjacent the outer side 14' of bulb 14, and the plug 48 being disposed within the inner end portion of tube 10 adjacent the opposite inner side 14" of bulb l4, and portion 10 of tube 10 having a larger diameter than the main body portion 10" of tube 10, to facilitate use of larger diameter plugs for easy manipulation of a syringe needle for inflation with the syringe. It will also be noted in the embodiment of FIG. 3 that a series of peripheral apertures 34', shown as four in number, are disposed in the wall of tube 10 a short distance beyond the outer sides 14 of the plug 14, and positioned in a plane substantially normal to the axis of tube 10, providing communication of the enclosed space 56 between plugs 46 and 48, and the intermediate inflatable member or bag 16.

FIG. 4 shows the specific arrangement of FIG. 3, butincluding a metal sleeve 38, containing the plugs 46 and 48 positioned in opposite ends thereof, the apertures 44' of the metal insert or sleeve 38 being disposed farther forward than in the case of the apertures 44 of sleeve 38 in FIG. 2, the apertures 44' of sleeve 38 communicating with the apertures 34 of tube 10.

- In this modification, sleeve 38' carries a flange 83 which rests against the inner edge 85 of tube 10 to position the sleeve properly in tube 10.

Although the embodiments of FIGS. 2 and 4 involve the use of an additional member, namely, the insert or sleeve 38 or 38, such sleeve is readily manufactured and the plugs 46 and 48 can be easily positioned therein and the resulting assembly then readily inserted into the inner end of tube 10. In the modification of FIG. 4, the sleeve and plug assembly is rotated to the proper registering position of the apertures 44 with the corresponding apertures 34 in the tube wall, as described above, by employing registering markings such as illustrated at A and .B at the inner ends of the tube and sleeve, respectively, as indicated in FIG. 4. The use of a metal sleeve such as 38 or 38' as shown in FIGS. 2 and 4 has the important advantage that it prevents accidental puncture of the tube 10 by the hypodermic needle of the syringe, if the needle is not introduced axially through the plugs 48 and 46, and is accidentally directed askew of the center of tube 10.

It will be understood that the concept of the present invention can be employed using only a single inflatable member such as 12 sealingly disposed around the closed outer end of the tube, without employing any intermediate inflatable member such as shown at 16 in FIG. 2. Thus, in the embodiment illustrated generally in FIG. 6, only the outer inflatable member 12 at the outer end of tube 10 is employed. This can be accomplished in the first place by omitting apertures 34', provided in the wall of tube 10 as illustrated in FIG. 3, and a single rubber plug 48 which is self sealing, as in the case of plug 48 of FIG. 3 is inserted into the open end portion 10 of tube 10. Note also in the embodiment of FIG. 6 that the additional plug, as indicated at 46 in FIG. 3 is omitted. The single inflatable balloon device of this modification can be inserted into the nasal cavity for control of postadenoidectomy bleeding, or can be used in certain instances to control nasal bleeding and wherein it may also be desirable to pack at least a portion of the nasal cavity with gauze for most effective control of bleeding.

The modification illustrated in FIG. 7 is similar to that of FIG. 6, except that plug 48 can be inserted into the tube 10 to the left of bulb 14 as viewed in FIG. 7,

the inner end portion 10' to the right of bulb 14 in FIG.

. 7 being shorter than end portion 10 of tube 10 in FIG.

The embodiment of FIG. 6 is preferred over that of FIG. 7, since one can more readily and quickly insert the needle of the syringe into the plug 48' at the extreme inner end of tube 10 in FIG. 6, whereas in FIG. 7, the needle of the syringe must be passed through tube 10 beyond the bulb 14 for insertion in plug 48.

Now referring to FIG. 8, it will be seen that the above-described devices of the invention, such as illustrated in FIGS. 2 and 6, can be modified so that the bulb 14 is not integrally molded or formed on the tube .10, but rather the tube 10 can be provided at its inner open end with a flange 90 of reduced wall thickness, and a separate assembly provided, comprising the bulb 14 and inner end portion 10, and having an outer I flange 92, the flanges 90 and 92 being secured together, as by means of a suitable adhesive, to assemble the tube and bulb portions.

In still another embodiment (not shown), in place of employing only a single inflatable intermediate bag 16, as seen in FIGS. 2 and 3, there can be employed a pair of such intermediate inflatable members. This can be accomplished, e.g. by modification of the embodiment of FIG. 2 to lengthen sleeve 38 and to provide an additional soft rubber plug in sleeve 38, spaced from and to the left of plug 46, in FIG. 2, with an additional set of registering apertures in the wall 10 of the tube and the sleeve 38, between said additional plug and plug 46, so as to permit independent inflation of the above-noted pair of intermediate inflatable members.

Water may be used to inflate the inflatable members, e.g. 12 and 16, since an exact amount of water can be easily measured and the volume displacement of the respective inflatable bags predetermined. Also, water does not permeate rubber walls as do many gases and the inflation of the bags remains relatively permanent until the water is drained from the inflatable balloons. However, air may be preferable since in the event of a balloon rupture, there would be no danger of aspirating water. I Y

The seals or plugs, e.g. 46 and 48, can be formed of any suitable soft rubber or plastic, which can be readily punctured by a syringe needle and are resealable upon removal of the needle. Thus, such plugs can be formed of materials of the above type which can be punctured by either a sharp or a blunt syringe needle.

Referringnow to FIGS. 9 to 15, the device is provided with a flexible tubular member 94 having an inflatable balloon 96 secured thereabout and sealed at its ends 98 to the tubular member 94. One or more openings 100 provide communication between the interior of the tubular member 94 and the interior of the balloon 96. The parts of this device are shaped and proportioned so that the inflatable balloon 96 stops nose bleeds by compressing the main artery to the interior of the nose (the sphenopalatine artery) as it enters the nasal cavity before it forms any branches. This feature is superior to that of other balloons which are designed to compress a branch of the artery at the point where the bleeding occurs. The reason that such other balloons are not as effective as the device of the present invention is because very often the bleeding branch lies in an area covered by an overhanding structure and therefore is not contacted by the balloon.

As best shown in FIGS. 11 and 12, the tubular member 94 near its open end is' enlarged in diameter to form a self-sustaining bulbous formation 102. The bulbous formation 102 has walls of substantially the same thickness as the flexible tube 94, which is sufficient for the bulbous formation or bulb 102 to be self-sustaining even in the absence of any internal pressure. As shown, the bulb 102 defines an annular inwardly facing chamber in communication with the interior of the tube 94. The bulb 102 not only serves as a safety feature to prevent the device from slipping into the patients throat and obstructing the airway, but it also holds the balloon in the proper position within the nose so that when the balloon 96 is inflated the wall thereof presses directly on the sphenopalatine artery and compresses it against the bone behind it.

A valve structure 104 is provided with a tubular body portion 106 extending into the open end portion 108 of tube 94 and a flange 110 thereon limits inward movement of the valve structure. An outer tubular portion 112 extends outwardly from the body portion 106. The tubular portion 112 is provided with a central bore 114 and the body portion 106 has an enlarged bore 116 therein. The region between the boxes 1 14 and 1 16 defines a valve seat 118. The bore 116 is provided with internal flutes or grooves 120, as best shown in FIG. 14. A solid body of rubber-like material 122 has an enlarged cylindrical portion occupying the bore 116 and a smaller cylindrical projection 124 extending outwardly into bore 114. A shoulder 126 on the body 122 normally seats against valve seat 118, it is maintained seated thereagainst by inwardly turned portions 128 at the inner end of tubular body portion 106 and is preferably maintained under very slight compression to provide a seal against the seat 118. The cylindrical portion 122 is provided with longitudinal ribs 130 and those ribs coupled with the channels 120 provide longitudinal passageways 132 for air around the body 122. As shown, the reduced cylindrical portion 124 is provided with a transverse groove or slot 134 at its outer end.

A suitable source of air under pressure, such as the syringe generally designated 136, is provided with a tubular nipple 138 of a size to be received within the bore 114 and of a length sufficient to engage the outer end of cylindrical extension 124 and to push the same inwardly to compress the valve body 122 and thus move the shoulder 126 away from valve seat 118. The transverse groove 134 ensures a passageway for air from the interior of nipple 138, around the cylindrical extension 124, past valve seat 118 and along passageways 132 to the interior of tube 94 for inflation of balloon 96. FIG. 12 shows the parts in their relative positions when the balloon 96 is being inflated. After the balloon 96 is sufficiently inflated, the nipple 138 is merely withdrawn from tubular extension 112 whereupon the body 122 resiliently expands to reseat its shoulder 126 against valve seat 118 and thereby retain the balloon 96 in inflated condition. Obviously, the balloon 96 may be deflated at will by merely reinserting the nipple 138 to the position of FIG. 12 and permitting the air to escape or actually withdrawing it by operation of the syringe 136.

It will be apparent from the foregoing description and the drawings herewith that the bulb 14 or 102, which has been referred to as semi-rigid has sufficient rigidity to be self-sustaining even in the absence of internal pressure. This fact is clear from the description and is also clearly exhibited by the form shown in FlG. 7 wherein the interior of the bulb 14 is never pressurized.

The term nasal tampon as employed in the specification and claims is intended to include use of the device also as a nasopharyngal tampon, as described above.

While I have described particular embodiments of my invention for the purpose of illustration, it should be understood that various other modifications and adaptations thereof may be made within the spirit of the invention, and hence the invention is not to be taken as limited except by the scope of the appended claims.

I claim:

1. A self-retaining nasal tampon comprising an elongated flexible tube open at one end and closed at its op posite end, a hollow self-sustaining bulb carried on said tube adjacent the open end portion thereof, and having a substantially larger diameter than the diameter of said tube, at least one inflatable member surrounding and sealingly attached to said tube remote from said bulb, said inflatable member being free to expand and form an inflated bag, passage means communicating the interior of said tube with said inflatable member to permit inflation thereof by fluid introduced into said tube and said inflatable member via passage means, said bulb being sufficiently rigid to be self-sustaining in the absence of internal pressure and thereby to prevent aspiration of the nasal tampon by a patient whether the inflatable member is inflated or deflated, and sealing means positioned in said tube adjacent said bulb, said sealing means having an inner portion in communication with said passage means and an outer portion located and arranged to permit communication between said inner portion and a source of fluid under pressure to permit inflation of said inflatable member, and to prevent deflation of said inflatable member after inflation thereof, a second inflatable member sealingly attached to said tube and disposed around said flexible tube intermediate the ends thereof and between said first mentioned inflatable member disposed around said closed end of said tube, and said bulb, said second inflatable member being free to expand and form an inflatable bag around the intermediate portion of said tube, said inflatable members being independently inflatable, second passage means communicating the interior of said tube and said second inflatable member to permit inflation thereof by fluid introduced into said second inflatable member, second sealing means positioned within said tube and spaced from said first mentioned sealing means, said second sealing means having an inner face in communication with said second passage means and an exterior face located and arranged to permit communication between said last mentioned inner face and a source of fluid under pressure, to permit inflation of said second inflatable member, and to prevent deflation of said second inflatable member upon inflation thereof.

2. A self-retaining nasal tampon as defined in claim 1, said second sealing means being positioned in the open end portion of said tube adjacent said bulb and said first mentioned sealing means being positioned in an intermediate portion of said tube on the opposite side of said bulb from said second sealing means.

3. A self-retaining nasal tampon as defined in claim 2, said tube being monoaxial, each of said sealing means being positioned within said single axial passage of said tube, said bulb being molded on said tube.

4. A self-retaining nasal tampon as defined in claim 1, said first mentioned sealing means and said second sealing means being spaced axially from each other along said axial passage of said tube, said sealing means each being capable of being selectively punctured by a needle without removal of said needle from said tube.

5. A self-retaining tampon as defined in claim 2, including an insert disposed in said tube adjacent the open end thereof and passing through said bulb, said insert being hollow and communicating at its inner end with said first mentioned passage means and said first inflatable member, said insert including channel means in the wall of said insert communicating with said second passage means and said second inflatable member, said sealing means each comprising a soft rubber plug, one of said plugs positioned in one end of said hollow insert adjacent said open end of said tube and the other of said plugs positioned in the opposite end of said insert, said channel means in said sleeve being; disposed between said plugs.

6. A self-retaining nasal tampon comprising an elongated flexible tube open at one end and closed at its opposite end, a hollow self-sustaining bulb molded on said tube integral therewith, adjacent the open end thereof, providing a short end portion of said tube between said bulb and the open end of said tube, said bulb having a substantially larger diameter than the diameter of said tube, a pair of independently inflatable members surrounding and sealingly attached to said tube, each said inflatable member being free to expand and form an inflated bag around said tube, a first one of said inflatable members being disposed adjacent and around said closed end of said flexible tube, and a second one of said inflatable members being disposed around said flexible tube intermediate the ends thereof and between said first inflatable member and said bulb, passage means communicating the interior of said tube with each of said inflatable members to permit selective inflation of said respective members by fluid introduced into said tube and said respective members via said passage means, and a pair of sealing means positioned within said tube, said sealing means being respectively located to permit inflation of each of said inflatable members independently, and to prevent deflation of said inflatable members after inflation thereof, said sealing means each comprising a soft rubber plug, said plug being capable of being punctured and being resealable, a first one of said plugs positioned in said tube to seal the portion of said tube between said closed end of said tube and said first plug, said sealed portion of said tube communicating with said first inflatable member via a first one of said passage means, and a second one of said plugs positioned in said tube and spaced from said first plug, said second plug disposed between said first plug and said open end of said tube and forming another sealed space in said tube between said first and second plugs, said last-mentioned sealed space communicating with said second inflatable member via a second one of said passage means.

7. A self-retaining nasal tampon as defined in claim 6, including a sleeve open at both ends and positioned in the inner end portion of said tube adjacent said open end thereof, said first and second plugs positioned in said sleeve, said sleeve including a third passage means, said third passage means registering with said second passage means in said tube.

8. A self-retaining nasal tampon comprising an elongated flexible tube open at one end and closed at its opposite end, a portion of said tube, adjacent its open end, being enlarged in diameter to define a hollow selfsustaining bulb having a substantially larger diameter than the diameter of said tube, at, least one inflatable member surrounding and sealingly attached to said tube remote from said bulb, said inflatable member being free to expand and form an inflated bag, passage means communicating the interior of said tube with said inflatable member to permit inflation thereof by fluid introduced into said tube and said inflatable member via said passage means, said bulb being sufficiently rigid to be self-sustaining in the absence of internal pressure and thereby to prevent aspiration of the nasal tampon by a patient whether the inflatable member is inflated or deflated, and normally closed valve means positioned in said tube adjacent said bulb, said valve means having an inner port in communication with said passage means and a movable valve portion located and arranged to be engaged by a tubular member connected to a source of fluid under pressure to be moved to valve open position thereby to. admit fluid under pressure to the interior of said tube for inflation of said inflatable member, and to move to closed position when said tubular member is withdrawn to prevent deflation of said inflatable member after inflation thereof.

9. A nasal tampon as defined in claim 8 wherein said movable valve member comprises a body of elastomeric material normally engaging a valve seat but being distortable away from said valve seat by said tubular member.

10. A nasal tampon as defined in claim 8 wherein said bulb defines an inwardly open bulbous chamber communicating with the interior of said flexible tube.

11. A nasal tampon as defined in claim 8 in which the inflatable member is positioned to stop nose bleeds by compressing the sphenopalatine artery where it enters the nasal cavity and before it forms any branches. 

1. A self-retaining nasal tampon comprising an elongated flexible tube open at one end and closed at its opposite end, a hollow self-sustaining bulb carried on said tube adjacent the open end portion thereof, and having a substantially larger diameter than the diameter of said tube, at least one inflatable member surrounding and sealingly attached to said tube remote from said bulb, said inflatable member being free to expand and form an inflated bag, passage means communicating the interior of said tube with said inflatable member to permit inflation thereof by fluid introduced into said tube and said inflatable member via passage means, said bulb being sufficiently rigid to be selfsustaining in the absence of internal pressure and thereby to prevent aspiration of the nasal tampon by a patient whether the inflatable member is inflated or deflated, and sealing means positioned in said tube adjacent said bulb, said sealing means having an inner portion in communication with said passage means and an outer portion located and arranged to permit communication between said inner portion and a source of fluid under pressure to permit inflation of said inflatable member, and to prevent deflation of said inflatable member after inflation thereof, a second inflatable member sealingly attached to said tube and disposed around said flexible tube intermediate the ends thereof and between said first mentioned inflatable member disposed around said closed end of said tube, and said bulb, said second inflatable member being free to expand and form an inflatable bag around the intermediate portion of said tube, said inflatable members being independently inflatable, second passage means communicating the interior of said tube and said second inflatable member to permit inflation thereof by fluid introduced into said second inflatable member, second sealing means positioned within said tube and spaced from said first mentioned sealing means, said second sealing means having an inner face in communication with said second passage means and an exterior face located and arranged to permit communication between said last mentioned inner face and a source of fluid under pressure, to permit inflation of said second inflatable member, and to prevent deflation of said second inflatable member upon inflation thereof.
 2. A self-retaining nasal tampon as defined in claim 1, said second sealing means being positioned in the open end portion of said tube adjacent said bulb and said first mentioned sealing means being positioned in an intermediate portion of said tube on the opposite side of said bulb from said second sealing means.
 3. A self-retaining nasal tampon as defined in claim 2, said tube being monoaxial, each of said sealing means being positioned within said single axial passage of said tube, said bulb being molded on said tube.
 4. A self-retaining nasal tampon as defined in claim 1, said first mentioned sealing means and said second sealing means being spaced axially from each other along said axial passage of said tube, said sealing means each being capable of being selectively punctured by a needle without removal of said needle from said tube.
 5. A self-retaining tampon as defined in claim 2, including an insert disposed in said tube adjacent the open end thereof and passing through said bulb, said insert being hollow and communicating at its inner end with said first mentioned passage means and said first inflatable member, said insert including channel means in the wall of said insert communicating with said second passage means and said second inflatable member, said sealing means each comprising a soft rubber plug, one of said plugs positioned in one end of said hollow insert adjacent said open end of said tube and the other of said plugs positioned in the opposite end of said insert, said channel means in said sleeve being disposed between said plugs.
 6. A self-retaining nasal tampon comprising an elongated flexible tube open at one end and closed at its opposite end, a hollow self-sustaining bulb molded on said tube integral therewith, adjacent the open end thereof, providing a short end portion of said tube between said bulb and the open end of said tube, said bulb having a substantially larger diameter than the diameter of said tube, a pair of independently inflatable members surrounding and sealingly attached to said tube, each said inflatable member being free to expand and form an inflated bag around said tube, a first one of said inflatable members being disposed adjacent and around said closed end of said flexible tube, and a second one of said inflatable members being disposed around said flexible tube intermediate the ends thereof and between said first inflatable member and said bulb, passage means communicating the interior of said tube with each of said inflatable members to permit selective inflation of said respective members by fluid introduced into said tube and said respective members via said passage means, and a pair of sealing means positioned within said tube, said sealing means being respectively located to permit inflation of each of said inflatable members independently, and to prevent deflation of said inflatable members after inflation thereof, said sealing means each comprising a soft rubber plug, said plug being capable of being punctured and being resealable, a first one of said plugs positioned in said tube to seal the portion of said tube between said closed end of said tube and said first plug, said sealed portion of said tube communicating with said first inflatable member via a first one of said passage means, and a second one of said plugs positioned in said tube and spaced from said first plug, said second plug disposed between said first plug and said open end of said tube and forming another sealed space in said tube between said first and second plugs, said last-mentioned sealed space communicating with said second inflatable member via a second one of said passage means.
 7. A self-retaining nasal tampon as defined in claim 6, including a sleeve open at both ends and positioned in the inner end portion of said tube adjacent said open end thereof, said first and second plugs positioned in said sleeve, said sleeve including a third passage means, said third passage means registering with said second passage Means in said tube.
 8. A self-retaining nasal tampon comprising an elongated flexible tube open at one end and closed at its opposite end, a portion of said tube, adjacent its open end, being enlarged in diameter to define a hollow self-sustaining bulb having a substantially larger diameter than the diameter of said tube, at least one inflatable member surrounding and sealingly attached to said tube remote from said bulb, said inflatable member being free to expand and form an inflated bag, passage means communicating the interior of said tube with said inflatable member to permit inflation thereof by fluid introduced into said tube and said inflatable member via said passage means, said bulb being sufficiently rigid to be self-sustaining in the absence of internal pressure and thereby to prevent aspiration of the nasal tampon by a patient whether the inflatable member is inflated or deflated, and normally closed valve means positioned in said tube adjacent said bulb, said valve means having an inner port in communication with said passage means and a movable valve portion located and arranged to be engaged by a tubular member connected to a source of fluid under pressure to be moved to valve open position thereby to admit fluid under pressure to the interior of said tube for inflation of said inflatable member, and to move to closed position when said tubular member is withdrawn to prevent deflation of said inflatable member after inflation thereof.
 9. A nasal tampon as defined in claim 8 wherein said movable valve member comprises a body of elastomeric material normally engaging a valve seat but being distortable away from said valve seat by said tubular member.
 10. A nasal tampon as defined in claim 8 wherein said bulb defines an inwardly open bulbous chamber communicating with the interior of said flexible tube.
 11. A nasal tampon as defined in claim 8 in which the inflatable member is positioned to stop nose bleeds by compressing the sphenopalatine artery where it enters the nasal cavity and before it forms any branches. 